Global® AP™ Total Shoulder Arthroplasty

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Device: Global® AP™ Total shoulder arthroplasty

• Registration Number: NCT00719771
• Lead Sponsor: DePuy Orthopaedics

Brief Summary

This study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis using the anchor pegged glenoid component and clinical and radiographic evaluations.

Detailed Description

The purpose of the study is to determine the difference between pre-operative and post-operative levels of patient satisfaction, shoulder function, radiographic alignment, shoulder pain and patient satisfaction in patients receiving a Global® AP™ shoulder prosthesis for glenohumeral arthritis.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-07-21
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-22
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-12
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients selected for inclusion will present for primary shoulder arthroplasty with a diagnosis of osteoarthritis and will consent to participate.

Exclusion Criteria

• Are under 18 years of age or over 70
• Diagnosis of AVN, Inflammatory Arthritis, Fracture or Malunion.
• Have a hemi-arthroplasty
• Have destruction of the proximal humerus that precludes rigid fixation of the humeral component
• Have arthritis with insufficient cuff tissue
• Have had a failed rotator cuff surgery
• Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified
• Have evidence of active infection
• Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint) - Have a known active metastatic or neoplastic disease
• Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol
• Are skeletally immature.
• Have a known allergic reaction to implant metals, polyethylene or a tissue reaction to corrosion or wear products
• Have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible
• Are currently participating in another clinical study
• Are taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery
• Are currently involved in any personal injury litigation, medical legal or worker's compensation claims.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Global® AP™ Shoulder	Global® AP™ Total shoulder arthroplasty	Global® AP™ Shoulder

Primary Outcome Measures

Name	Time	Method
Constant Shoulder Score	Pre-op, 6, 12, 24 months

Secondary Outcome Measures

Name	Time	Method
SF-12	Pre-op, 6,12, 24 months
Penn/ASES	Pre-Op, 6, 12, and 24 months
Radiographic Data	Pre-Op, 6 weeks, 6, 12, and 24 months
Quality of Life Survey	6 weeks

Trial Locations

Locations (4)

Mission Hospitals Research Institute; 🇺🇸 Asheville, North Carolina, United States

Wellington Orthopaedics and Sports Medicine; 🇺🇸 Cincinnati, Ohio, United States

Rosenberg Cooley Metcalf Clinic; 🇺🇸 Park City, Utah, United States

The CORE Institute; 🇺🇸 Phoenix, Arizona, United States